Docket Management
Docket: 01N-0078 - Assessment Attitudes Toward Direct-to-Consumer Promo of Prescription Drugs
Comment Number: EC -11

Accepted - Volume 1

Comment Record
Commentor Mr. Mark Cloutier Date/Time 2001-05-18 17:02:47
Organization RxHealthValue
Category Consumer Group

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? RxHealthValue is writing to offer comments on the direct-to-consumer (DTC) advertising survey to physicians and consumers. We are supportive of the FDA’s efforts to gather empirical data on the experience and effects of DTC promotion (66 FR 15494) RxHealthValue is committed to improve American’s access to health improving drugs. We are concerned about the growing frequency of DTC ads and their effect on appropriate medical care seeking and pharmaceutical requesting behavior. In particular, we are concerned about the amount and kind of risk information that is given in television advertising. The regulation of broadcast and print advertising has evolved as an experiment from a regulatory structure intended for physicians and physician-directed promotion. Physicians, a priori, have a higher educational, reading and technical proficiency in the content of pharmaceutical promotion. We believe this framework has led to a set of regulatory practices which are not based on an adequate understanding of how consumers read, hear, process and act on product information. While this docket is focused on the issue of collections of information on two surveys, we believe that the preceding issues of the regulatory structure which this information collection may be used to modify, deserves a fundamental rethinking. DTC advertising regulation should be fundamentally revised based on a better understand of how consumers hear and read information, how it effects their ability to self assess and self diagnose, their comprehension of indications, contraindications, risk, polypharmacy and drug interactions. The proposed consumer survey is a valuable contribution to this growing literature. We believe, however, that the time has come to rethink the “brief summary” requirement and the “fair balance” doctrine. Fundamentally, we are concerned that the FDA regulates the product-claim ads more rigorously than the “see your doctor” and “reminder ads.” Product claim ads display information which, we believe, based on the Prevention Magazine research on risk and benefit retention, inadequately display side effects, contrindications and indicated uses. The “see your doctor” and “reminder ads’ then, reinforce brand and product seeking behavior flowing from an already inadequate retention of risk information. In short, the public health value of these ads from a safety perspective has become completely subordinated to the brand and product retention messaging. We are concerned how this may contribute to medically inappropriate demands for drugs resulting in wasted physician clinic time and wasted consumer dollars. We are also concerned about the potential contribution to medical error in prescribing and utilization.
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? We believe that the validty of the methodology and the assumption used in the consumer survey raises substantial questions. Our concern is that this survey is an attitudinal survey as oppossed to a behavioral survey. Understanding the effect of advertising copy and visual and auditory images on television on actual behavior is what is needed. Consistent with the study conducted by the FDA in 1983-1985, later studies such as the Prevention Magazine study demonstate that consumers retain more benefit than risk information. Growing linguistic variation and the aging of the population with predictable reductions in memory and recall all suggest the the FDA needs better behavioral data related to medical literacy and cognitive studies about comprehension, recall and pharmaceutical use. Our concern focusses on safety as the increasing amount of information leads to greater utulization and the possiblity of polypharmacy and misuse grows.
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? General Comments on the Phyician Survey: We recommend that you add a question about the frequency of patients asking to change medications, as well as asking about new medications. We recommend that you ask why the doctor may have felt pressure (i.e. satisfying the patient) We recommend if doctors have information available for counter-detailing to educate patients about proper indications and uses of requested/and or prescribed medications. The FDA should ad a question asking whether the physician is Board certified. Lastly, the issues of a patient requesting a drug for a condition they do not have should be broken out as a seperate question with futher questions about advertising and recall which led to the request for the drug. General Comments on the Consumer Survey: See comments above on attitudinal vs. behavioral survey

EC -11